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Under the Community method, policy is largely the by-product of actions undertaken to advance the integration process or to preserve institutional balance, rather than to solve concrete problems efficiently. The policy that eventually emerges is all too often the best bargain that can be negotiated politically. This chapter discusses some clear-cut cases of policy failure, such as the common fisheries and agricultural policies. EU environmental policy is shown to lack a clear rationale, and highly uncertain in its actual results. Risk regulation is a particularly interesting case. The central tenet of EU risk policy — the precautionary principle — is logically defective, tends to distort, rather than clarify regulatory priorities, and has isolated the EU internationally on several occasions.

This introductory chapter has two aims. First, it examines regulation as a topic for study; reviews major developments in regulation; and outlines central themes in regulation. Second, it presents an argument. Section 2 looks at approaches to the definition of regulation. Section 3 describes landmarks in British regulatory theory and practice. Section 4, 5, and 6 considers major themes. Section 7 asks whether regulation is entering its prime as a science or approaching difficult mid-life crisis. It suggests that if regulatory science is to develop free from such a mid-life crisis, a number of themes should be explored further.

Chapter 5 examines scientists’ efforts to facilitate the diffusion of a specific molecular practice-toxicogenomics-from the laboratories of the National Cancer Institute (NCI) and the NIEHS to the regulatory review protocols of the EPA. It demonstrates that the efforts of scientists, bioethicists, lawyers, and policymakers to anticipate and address the requirements of environmental risk assessment at the EPA have been an intrinsic part of the development of the science itself. It also describes the emergence of new initiatives, such as Tox21, a collaboration between the National Institutes of Health and the Environmental Protection Agency

This chapter focuses on how institutional environmental policy and the development of environmental justice have changed “regulatory science” and “street science” in pesticide monitoring and regulation in California. It examines innovative regulatory and social efforts having the ability to fulfil the goals of environmental justice. The chapter also shows how the emerging New Political Sociology of Science perspective explores ways in which normally accepted rules, procedures, networks, and resources create the power for producing knowledge and the dynamics of opposition and adjustments. It analyzes case studies and reveals that environmental justice efforts have resulted in unequal changes in the regulatory and street sciences of pesticide monitoring and regulation in California. The chapter also highlights the opportunities and challenges imposed on regulators and activities by the larger political economic community in dealing with these issues.

The regulatory evolution of medical technologies in the EU offers a unique perspective with regard to highlighting significant elements of both European science policy and the development of European institutions, especially with regard to the passage from their (primarily) economic to their political phases. Since the early 1990s, while establishing a market for biotechnology, the European Communities have been developing some policy-related visions of technoscience and its potential risks, while at the same time framing the concept of European citizenship through European values and rights. The emerging and re-emerging medical technology of xenotransplantation, namely the clinical use of cells, tissues, and organs between species, while having evolved from its primary focus on organs to so-called advanced therapies (cell therapy, gene therapy, and tissue-engineered products), also provided an opportunity to test and implement different science policy models in dealing with risks and uncertainties in the European knowledge-based and innovation-oriented society.

The chapter discusses how an internal conflict between two groups of researchers within the Regional Cancer Centre at Thiruvananthapuram in the context of clinical trials triggered a public controversy on the regulation of drug research. The credibility of the cancer research institute was at stake, and the public trust on the researchers deteriorated. The chapter demonstrates how the trust in the scientific community has been regained and the credibility of the institute restored through a complex deliberative process wherein media institutions, scientists, health activists, government officials and national regulatory bodies participated. The involvement of the Johns Hopkins University, USA, in the clinical trials triggereda debate on the changing dynamics of drug research in the neoliberal context. The controversy was one of the earliest of its kind which alerted the medical research community and policy makers about the escalating commercial interests in the drugs and pharmaceuticals sector in India.

The concept of ‘scientific public sphere’ is developed in the chapter. The structural coupling of science with media and politics in contemporary liberal democracies has led to the emergence of the scientific public sphere as a deliberative space to negotiate modernization risks, a phenomenon that has radically altered the characteristics of the scientific-citizen publics. The scientific public sphere gets activated when public controversies over science are staged by the mass media. The deliberative turn in public engagement with science and the recent developments in understanding the interaction between science and media are discussed in the chapter to theorize mediated public engagement with science in contemporary risk societies. It is argued that present conceptualization of ‘medialization of science’ is insufficient to capture the dynamics between science, mass media, and risk politics, and the chapter proposes scientific public sphere as a better framework.

The current protectionist paradigm for ethical review of human subjects research is based on an implicit assumption that scientists, left on their own, are either unable or unwilling to fulfil their personal responsibilities to ensure the safety and well-being of individuals participating in their studies. A sound ethical framework exists, but a well-intended effort to implement its principles through rules, regulation and guidance has failed to achieve its intended goals. The resulting process itself is excessively focused on achieving regulatory compliance at the expense of meaningful ethical consideration. Calls for reform focus on relieving regulatory burdens and expediting review and approval without substantively changing the underlying protectionist assumptions. Consistent with modern regulatory science, a pragmatic alternative paradigm based on existing and proven models of professionalism is proposed to address these challenges with greater effectiveness and efficiency. This new approach would require that investigators and research teams be appropriately qualified, assume responsibility for their actions, and aspire to the values delineated by Henry Beecher more than half a century ago—a reasonable and achievable, although so far elusive, goal.